Local Anesthesia Before Bulkamid Injection
Purpose
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.
Conditions
- Stress Urinary Incontinence
- Intrinsic Sphincter Deficiency
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG - English-speaking - Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia
Exclusion Criteria
- Pregnancy - Neurogenic bladder - Pre-existing need for intermittent catheterization or indwelling catheter - Bladder or urothelial malignancy - Prior radiation to pelvic floor - Known allergy/sensitivity to PAHG
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Topical anesthesia alone |
2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min |
|
Active Comparator Topical anesthesia with periurethral block |
2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min + periurethral block (5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock to depth of 1.5 cm using 25G needle) Block sits for 5 min if lidocaine, 10 min if bupivacaine |
|
Recruiting Locations
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
MedStar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
MedStar Lafayette Medical Centre
Washington, District of Columbia 20036
Washington, District of Columbia 20036
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute